Algor-ethics: charting the ethical path for AI in critical care.

The integration of Clinical Decision Support Systems (CDSS) based on artificial intelligence (AI) in healthcare is groundbreaking evolution with enormous potential, but its development and ethical implementation, presents unique challenges, particularly in critical care, where physicians often deal with life-threating conditions requiring rapid actions and patients unable to participate in the decisional process. Moreover, development of AI-based CDSS is complex and should address different sources of bias, including data acquisition, health disparities, domain shifts during clinical use, and cognitive biases in decision-making. In this scenario algor-ethics is mandatory and emphasizes the integration of 'Human-in-the-Loop' and 'Algorithmic Stewardship' principles, and the benefits of advanced data engineering. The establishment of Clinical AI Departments (CAID) is necessary to lead AI innovation in healthcare, ensuring ethical integrity and human-centered development in this rapidly evolving field.

Medical Ethics, Moral Courage, and the Embrace of Fallibility.

Experts have an obligation to make difficult decisions rather than offloading these decisions onto others who may be less well equipped to make them. This commentary considers this obligation through the lens of drafting critical care rationing protocols to address COVID-19-induced scarcity. The author recalls her own experience as a member of multiple groups charged with the generation of protocols for how hospitals and states should ration critical care resources like ventilators and intensive care unit beds, in the event that there would not be enough to go around as the COVID-19 pandemic intensified. She identifies several obvious lessons learned through this process, including the need to combat the pervasive effects of racism, ableism, and other forms of discrimination; to enhance the diversity, equity, and inclusion built into the process of drafting rationing protocols; and to embrace transparency, including acknowledging failings and fallibility. She also comes to a more complicated conclusion: Individuals in a position of authority, such as medical ethicists, have a moral obligation to embrace assertion, even when such assertions may well turn out to be wrong. She notes that when the decision-making process is grounded in legitimacy, medical ethics must have the moral courage to embrace fallibility.

Frequency and Severity of Moral Distress in Nephrology Fellows: A National Survey.

INTRODUCTION: Moral distress is a negative affective response to a situation in which one is compelled to act in a way that conflicts with one's values. Little is known about the workplace scenarios that elicit moral distress in nephrology fellows. METHODS: We sent a moral distress survey to 148 nephrology fellowship directors with a request to forward it to their fellows. Using a 5-point (0-4) scale, fellows rated both the frequency (never to very frequently) and severity (not at all disturbing to very disturbing) of commonly encountered workplace scenarios. Ratings of ≥3 were used to define "frequent" and "moderate-to-severe" moral distress. RESULTS: The survey was forwarded by 64 fellowship directors to 386 fellows, 142 of whom (37%) responded. Their mean age was 33 ± 3.6 years and 43% were female. The scenarios that most commonly elicited moderate to severe moral distress were initiating dialysis in situations that the fellow considered futile (77%), continuing dialysis in a hopelessly ill patient (81%) and carrying a high patient census (75%), and observing other providers giving overly optimistic descriptions of the benefits of dialysis (64%). Approximately 27% had considered quitting fellowship during training, including 9% at the time of survey completion. CONCLUSION: A substantial majority of nephrology trainees experienced moral distress of moderate to severe intensity, mainly related to the futile treatment of hopelessly ill patients. Efforts to reduce moral distress in trainees are required.

The need to show minimum clinically important differences in Alzheimer's disease trials.

Deciding on the smallest change in an outcome that constitutes a clinically meaningful treatment effect (ie, the minimum clinically important difference [MCID]) is fundamental to interpreting clinical trial outcomes, making clinical decisions, and designing studies with sufficient statistical power to detect any such effect. There is no consensus on MCIDs for outcomes in Alzheimer's disease trials, but the US Food and Drug Administration's consideration of aducanumab clinical trials data has exposed the uncertainty of the clinical meaning of statistically significant but small improvements. Although MCIDs for outcomes, including Clinical Dementia Rating-Sum of Boxes and Mini-Mental State Examination in Alzheimer's disease have been reported, the Food and Drug Administration's guidelines, drafted in 1989 to facilitate regulatory approval of substantially effective antidementia drugs, do not specify quantified minimum differences. Although it is important that regulatory requirements encourage drug development and approval, without MCIDs, sponsors are motivated to power trials to detect statistical significance for only small and potentially inconsequential effects on clinical outcomes. MCIDs benefit patients, family members, caregivers, and health-care systems and should be incorporated into clinical trials and drug development guidance for Alzheimer's disease.

Assessment of capacity to give informed consent for medical assistance in dying: a qualitative study of clinicians' experience.

BACKGROUND: Under the Canadian Criminal Code, medical assistance in dying (MAiD) requires that patients give informed consent and that their ability to consent is assessed by 2 clinicians. In this study, we intended to understand how Canadian clinicians assessed capacity in people requesting MAiD. METHODS: This qualitative study used interviews conducted between August 2019 and February 2020, by phone, video and email, to explore how clinicians assessed capacity in people requesting MAiD, what challenges they had encountered and what tools they used. The participants were recruited from provider mailing listserves of the Canadian Association of MAiD Assessors and Providers and Aide médicale à mourir. Interviews were audio-recorded and transcribed verbatim. The research team met to review transcripts and explore themes as they emerged in an iterative manner. We used abductive reasoning for thematic analysis and coding, and continued to discuss until we reached consensus. RESULTS: The 20 participants worked in 5 of 10 provinces across Canada, represented different specialties and had experience assessing a total of 2410 patients requesting MAiD. The main theme was that, for most assessments, the participants used the conversation about how the patient had come to choose MAiD to get the information they needed. When the participants used formal capacity assessment tools, this was mostly for meticulous documentation, and they rarely asked for psychiatric consults. The participants described how they approached assessing cases of nonverbal patients and other challenging cases, using techniques such as ensuring a quiet environment and adequate hearing aids, and using questions requiring only "yes" or "no" as an answer. INTERPRETATION: The participants were comfortable doing MAiD assessments and used their clinical judgment and experience to assess capacity in ways similar to other clinical practices. The findings of this study suggest that experienced MAiD assessors do not routinely require formal capacity assessments or tools to assess capacity in patients requesting MAiD.

Defining laboratory medicine, or squaring the circle?

In the August 2020 issue of Clinical Chemistry and Laboratory Medicine, Giuseppe Lippi and Mario Plebani proposed a definition of laboratory medicine, which ends with this sentence: "The results of these measurements are translated into actionable information for improving the care and/or maintaining the wellness of both a single individual and an entire population". Nevertheless, the selfishness of individuals may, sometimes, jeopardize the interest of whole populations. The virtue of justice being within the reach of the entire human community more than of single individuals, the final sentence in the definition proposed by Giuseppe Lippi and Mario Plebani, should therefore, in our view, be rewritten, less selfishly, for example like this: "For a given investment, these measurements are preferably made when they bring as much beneficence, and non-maleficence, as possible to the whole population".

Review of economic analysis of available interventions on idiopathic short stature: A protocol for systematic review and meta-analysis.

BACKGROUND: Idiopathic short stature (ISS) causes a high economic burden worldwide. As part of a research project that synthesizes economic evidence for Korean medicine treatment of ISS, we describe the methods that will be used for the comprehensive review of articles that analyze health-related economic evaluation for available interventions for ISS using a systematic review methodology. METHODS: Eight electronic English, Korean, and Chinese databases will be searched from their inception until December 2020 to identify studies on the economic evaluation of available interventions on ISS, without language, study design, or publication status restrictions. From the included studies, the effectiveness, utility, and cost data will be collected as the outcome measures by two researchers independently. Descriptive analysis of individual studies will be conducted. If it is judged that the interventions and outcomes of the included studies are sufficiently homogeneous, we will attempt a quantitative synthesis through meta-analysis using Review Manager version 5.4 software (Cochrane, London, UK). RESULTS: This study will summarize the evidence regarding the economic evaluation of available interventions for ISS. CONCLUSIONS: The findings of this review will help clinicians and patients in evidence-based decision-making in clinical settings and help policy makers develop effective policies and distribute resources based on the available evidence.

Machine Learning: The Next Paradigm Shift in Medical Education.

Machine learning (ML) algorithms are powerful prediction tools with immense potential in the clinical setting. There are a number of existing clinical tools that use ML, and many more are in development. Physicians are important stakeholders in the health care system, but most are not equipped to make informed decisions regarding deployment and application of ML technologies in patient care. It is of paramount importance that ML concepts are integrated into medical curricula to position physicians to become informed consumers of the emerging tools employing ML. This paradigm shift is similar to the evidence-based medicine (EBM) movement of the 1990s. At that time, EBM was a novel concept; now, EBM is considered an essential component of medical curricula and critical to the provision of high-quality patient care. ML has the potential to have a similar, if not greater, impact on the practice of medicine. As this technology continues its inexorable march forward, educators must continue to evaluate medical curricula to ensure that physicians are trained to be informed stakeholders in the health care of tomorrow.

Topical corticosteroid vehicle composition and implications for clinical practice.

This narrative review highlights the therapeutic significance of topical corticosteroid (TCS) vehicles and provides subsequent guidance to improve clinical and research outcomes. A greater understanding of the relationship between the topical vehicle, corticosteroid and skin is needed to ensure safer, more effective treatment for patients. Topical vehicles are not inert and can affect TCS bioavailability, due to the ability of their composition to positively or negatively influence skin status and change the physiochemical characteristics of an inherent corticosteroid. However, this principle is not commonly understood, and has contributed to inconsistencies in potency classification systems. This review provides an insight into the research methods and standardization needed to determine TCS product bioavailability. It identifies formulation components responsible for vehicle composition that underpin the quality, stability, compounding and functionalities of vehicle ingredients. This helps to contextualize how topical vehicles can be responsible for clinically significant effects, and how their composition gives products unique properties. In turn, this facilitates a more in-depth understanding of which resources offer information to inform the best selection of TCS products and why products should be prescribed by brand or manufacturer. This review will better equip clinicians and formulary teams to appraise products. It will also inform prescribing of Specials and why products should not be manipulated. The recommendations, accompanied by patient perspectives on using TCS products, assist clinical decision-making. They also identify the need for research into concomitant application of TCS products with other topical therapies.

Rationing care by frailty during the COVID-19 pandemic.

The coronavirus disease 2019 (COVID-19) pandemic is disproportionately affecting older people and those with underlying comorbidities. Guidelines are needed to help clinicians make decisions regarding appropriate use of limited NHS critical care resources. In response to the pandemic, the National Institute for Health and Care Excellence published guidance that employs the Clinical Frailty Scale (CFS) in a decision-making flowchart to assist clinicians in assessing older individuals' suitability for critical care. This commentary raises some important limitations to this use of the CFS and cautions against the potential for unintended impacts. The COVID-19 pandemic has allowed the widespread implementation of the CFS with limited training or expert oversight. The CFS is primarily being used to assess older individuals' risk of adverse outcome in critical care, and to ration access to care on this basis. While some form of resource allocation strategy is necessary for emergencies, the implementation of this guideline in the absence of significant pressure on resources may reduce the likelihood of older people with frailty, who wish to be considered for critical care, being appropriately considered, and has the potential to reinforce the socio-economic gradient in health. Our incomplete understanding of this novel disease means that there is a need for research investigating the short-term predictive abilities of the CFS on critical care outcomes in COVID-19. Additionally, a review of the impact of stratifying older people by CFS score as a rationing strategy is necessary in order to assess its acceptability to older people as well as its potential for disparate impacts.

No body is expendable: Medical rationing and disability justice during the COVID-19 pandemic.

The health threat posed by the novel coronavirus that caused the COVID-19 pandemic has particular implications for people with disabilities, including vulnerability to exposure and complications, and concerns about the role of ableism in access to treatment and medical rationing decisions. Shortages of necessary medical equipment to treat COVID-19 have prompted triage guidelines outlining the ways in which lifesaving equipment, such as mechanical ventilators and intensive care unit beds, may need to be rationed among affected individuals. In this article, we explore the realities of medical rationing, and various approaches to triage and prioritization. We discuss the psychology of ableism, perceptions about quality of life, social determinants of health, and how attitudes toward disability can affect rationing decisions and access to care. In addition to the grassroots advocacy and activism undertaken by the disability community, psychology is rich in its contributions to the role of attitudes, prejudice, and discriminatory behavior on the social fabric of society. We call on psychologists to advocate for social justice in pandemic preparedness, promote disability justice in health care settings, call for transparency and accountability in rationing approaches, and support policy changes for macro- and microallocation strategies to proactively reduce the need for rationing. (PsycInfo Database Record (c) 2021 APA, all rights reserved).

Rationing care in COVID-19: if we must do it, can we do better?

The COVID-19 pandemic has seen a proposal for frailty to be used as a rationing criterion. This commentary suggests circumstances under which that is defensible: in the face of lack of capacity to treat everyone, and as an alternative to age in stratifying risk. How best to stratify risk is likely to evolve and may include information about illness severity and dynamic measures. Current research must focus on mobilizing better, COVID-19-specific prognostic information, with a goal of best discriminating which lives are most and least likely to be saved should scarcity of resources dictate that not everyone can receive critical care.

Navigating Ethical Practices in the Era of High Cost Hematology.

PURPOSE OF REVIEW: In this review article, we will highlight ethical issues faced by hematologists due to a growing constellation of expensive diagnostics and therapeutics in hematology. We outline the important issues surrounding this topic including stakeholders, cost considerations, and various ethical challenges surrounding access to care, communication about costs, and individual vs. societal responsibilities. We review available tools to navigate these ethical themes and offer potential solutions. RECENT FINDINGS: We identified several gaps in the literature on the topic of ethical issues in hematology treatment and supplement by non-hematological cancer and general medical literature. We propose proactive solutions to address these problems to include cost transparency, utilization of evidence-based decision making tools, application of the four quadrant approach to ethical care, and advanced systems-based practice curriculum for physician trainees.

Ethical dilemmas in COVID-19 times: how to decide who lives and who dies?

The respiratory disease caused by the coronavirus SARS-CoV-2 (COVID-19) is a pandemic that produces a large number of simultaneous patients with severe symptoms and in need of special hospital care, overloading the infrastructure of health services. All of these demands generate the need to ration equipment and interventions. Faced with this imbalance, how, when, and who decides, there is the impact of the stressful systems of professionals who are at the front line of care and, in the background, issues inherent to human subjectivity. Along this path, the idea of using artificial intelligence algorithms to replace health professionals in the decision-making process also arises. In this context, there is the ethical question of how to manage the demands produced by the pandemic. The objective of this work is to reflect, from the point of view of medical ethics, on the basic principles of the choices made by the health teams, during the COVID-19 pandemic, whose resources are scarce and decisions cause anguish and restlessness. The ethical values for the rationing of health resources in an epidemic must converge to some proposals based on fundamental values such as maximizing the benefits produced by scarce resources, treating people equally, promoting and recommending instrumental values, giving priority to critical situations. Naturally, different judgments will occur in different circumstances, but transparency is essential to ensure public trust. In this way, it is possible to develop prioritization guidelines using well-defined values and ethical recommendations to achieve fair resource allocation.